Medical device recalls Moderate risk

Guangzhou Improve Medical Instruments Co., Ltd. recalls Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collectio…

Recall date
September 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1217-2019
FDA classification
Class II
Brand / firm
Guangzhou Improve Medical Instruments Co., Ltd.
Sold / distributed
US Nationwide distribution in the state of Kansas.

Why it was recalled

Complain due to the hub needle came out when the nurse draw the blood and removed the tube.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

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